510(k) · Cleared
ClearedPerfect Tissue Contouring System II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coltene/Whaledent, Inc. · EKZ Unit, Electrosurgical, And Accessories, Dental
Cleared on Oct 18, 2007 as substantially equivalent to K850666 (Ipco Corp., 1985) after a 126-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Oct 18, 2007
- Review
- 126 days
- Class
- Class II
- Product code
- EKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K850666 (1985). No later device cites it as a predicate yet.
- Root · 1 generation backK850666 Strobex Ultron Electrosurge-Dental UnitIpco Corp. · 1985
- This deviceK071632 Perfect Tissue Contouring System IIColtene/Whaledent, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K850666 | Strobex Ultron Electrosurge-Dental Unit | Ipco Corp. | 1985 | — |
| 0 (this device) | K071632 | Perfect Tissue Contouring System II | Coltene/Whaledent, Inc. | 2007 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EKZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EKZ device
- #1 K213477 Root ZX3score 5.3 · 6 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K850666 | Strobex Ultron Electrosurge-Dental UnitSummary page 1…Product Code - EKZ Classification - Class II Predicate The Stron Electrosurge Unit that is legally marketed under 510(k) K850666. Device The PerFect® TCS II is intended only for use by licensed dental practitioners who have received Inten… | 1985 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All EKZ devicesEKZ Unit, Electrosurgical, And Accessories, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · EKZ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · EKZ
Too few EKZ 510(k)s in any year since 2007 to give a median.
Recalls per year · EKZ
No recall names EKZ since 2007.
Adverse event reports per year · EKZ
6in 2018
MAUDE reports naming product code EKZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PerFect® TCS II is intended to cut or remove soft tissue or to control bleeding during dental
and periodontal surgical procedures in the oral cavity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071632 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071632: Perfect Tissue Contouring System II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071632
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026